Kornimate/medical-research-clean huggingface dataset:
bruog 351: pre-operative apbi using nibb

Conditions: Breast Cancer; Invasive Breast Cancer; Ductal Carcinoma in Situ

Summary: partial breast irradiation is typically performed after surgical removal of the tumor. partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. this study is evaluating the use of partial breast irradiation with nibb performed before surgery instead of after surgery.this should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome. in this study partial breast treatment will be given with nibb in 5 treatments over about 1 week. surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.


Eligibility criteria:
inclusion criteria: * confirmed histological diagnosis of invasive breast carcinoma and/or dcis (invasive lobular carcinoma excluded); * age greater or equal to 60 years old; * life expectancy \> 6 months; * candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon * clinically lymph node negative (cn0) as confirmed in writing by patient's treating physician. if patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cn0. * tumor size by imaging ≤ 2cm; (tis or t1) * estrogen receptor positive if invasive disease (dcis can be er negative); * her2neu negative if invasive disease; * nuclear grade 1 or 2 if invasive disease (dcis can be grade 3); * ecog performance status of 0-2 (appendix 1); * informed consent signed. exclusion criteria: * excisional biopsy or ipsilateral breast surgery within 6 months; * invasive lobular histology; * definitive lvsi on biopsy; * suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign; * paget's disease of the nipple * distant metastases; * known brca 1/2 mutation * active lupus or scleroderma,; * psychiatric or addictive disorder that would preclude attending follow-up; * neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted); * breast implants; * tumor not well visualized on accuboost imaging; * breast separation with compression \> 8cm at time of simulation.
heart aging when near vision difficulty begins

Conditions: Aging

Summary: near vision deterioration during aging results from a decrease in accomodation amplitude (aa). myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. thus, the investigators investigated the association between cardiac aging and aa. the subjects (500, mean 50-year-old subjects, with equal males and females) were divided into two groups according to aa measured with a raf ruler. biomicroscopy was used to capture images of the lens nucleus in the unaccommodated state, followed by images of a 4 diopter (d) accommodated state. the nucleus diameter change at 1 d accomodation was measured using imagej. cardiac conduction system differences were evaluated using electrocardiography, and cardiac autonomic aging was assessed based on heart rate variability. myocardial aging was assessed based on diastolic dysfunction.

lens cells and proteins are encapsulated, and they are not turned over or replaced.the lens nucleus starts to form before birth, so the nucleus is one of the three oldest tissues in the body .with aging, continuous cardiomyocyte stress derails proteostasis by causing excessive autophagy and protease activation, and, ultimately, contractile and electrophysiological dysfunction. aggregate deposition, proteostasis deterioration, and diffusion degradation between the nucleus and cortex are the main reasons for lens aging.heart, lens, and neuronal cells change significantly with age, and they are older than cells from renewable tissues. near vision deterioration during aging results from a decrease in accomodation amplitude (aa). cardiac aging is an independent risk factor for cardiovascular disease. thus, the investigators investigated the association between cardiac aging and aa. the subjects (500 mean 50-year-old subjects, with equal males and females) were divided into two groups according to aa measured with a raf ruler. the nucleus diameter change at 1 d accomodation was measured using imagej. cardiac conduction system differences, autonomic aging, myocardial aging were evaluated using electrocardiography, heart rate variability and diastolic dysfunction. for near distance vision,compared to subjects who could see clearly from 24-28 cm, subjects who could see clearly from 29-33 cm had a 2.104-fold higher risk of a lateral e' velocity \ 3.1, \[95%ci;1.085-2.197\]. subjective aa measurement can predict important heart aging parameters.

Eligibility criteria:
inclusion criteria: healthy volunteers, mean 50 years of age (49-51) exclusion criteria: hypertension, diabetes mellitus, atrial fibrillation, coronary artery disease, arrhythmia, hyperthyroidism , anemia, heart failure, respiratory diseases, severe obesity (body mass index ≥35 kg/m2),

Keywords: aging heart aging presbyopia
phase i study evaluating the safety and efficacy of a device for collection of electrical bioimpedance data

Conditions: Pain

Summary: the objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle.


Eligibility criteria:
inclusion criteria: 1. male or females 18 - 60 years of age 2. imaging spine study (ct or mri) in previous 3 months. 3. american society of anesthesiologists (asa) class i-iii 4. patients undergoing elective standard pain relief treatment of epidural steroid injection 5. patients must be willing to participate in the study, and provide written informed consent 6. women of child bearing potential must have a negative pregnancy test during the screening and baseline visits or the patient must be surgically sterile or be at least one year postmenopausal 7. women of child-bearing potential must be using a medically acceptable method of birth control throughout the study such as: bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of the following: diaphragm, cervical cap, condom or spermicide. exclusion criteria: 1. any contraindications for epidural injection 2. patient with severe scoliosis 3. previous spinal surgery, or any additional surgical intervention in the level of epidural injection other than elective standard pain relief treatment of epidural steroid injection. 4. documented, known or per examination neurological deficiency in lower extremities. 5. pregnant or breastfeeding patients 6. patients who have participated in another study within 30 days of enrolment 7. investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study i.e. known coagulopathy or recent use of anticoagulants or anti aggregates. 8. presence of fever, sepsis or infection near the point of insertion or an infection in the bloodstream which may "seed" onto the catheter 9. patients with known hypovolemia 10. any known anatomical abnormalities, such as spina bifida, meningomyelocele or scoliosis 11. patient suffering problems of the central nervous system, including multiple sclerosis or syringomyelia 12. patients with identified heart-valve problems 13. patients excessively hirsute where the surface electrodes are to be placed that are unwilling to shave these areas.

Keywords: patients undergoing elective pain relief treatment of lumbar epidural steroid injection under fluoroscopy
cross bracing protocol with and without dynamic neuromuscular stabilization training in athletes

Conditions: Sports Physical Therapy

Summary: acl injury is a severe injury for athletes, which frequently results in functional limits and a higher likelihood of re-injury. although bracing regimens are frequently used in rehabilitation, their ability to restore functional movements after an acl injury is still uncertain. dynamic neuromuscular stabilization (dns) training, which targets the core and proprioception, has emerged as a viable method for enhancing motor control and decreasing knee instability. the objective of this study is to examine the synergistic impact of cross bracing and dns training on the functional movements of athletes who have recently experienced an acl injury . a randomized controlled trial will be conducted to study the effects of different interventions on athletes with acute acl injury. the participants will be divided into two groups: (a= control group) cross bracing with conservative treatment, (b= treatment group) cross bracing + dns training with conservative treatment. both groups will engage in targeted exercises that aim to activate the core, improve proprioception, and enhance movement patterns. the participants' functional movements will be assessed at the beginning of the study and 6 weeks later using established questionnaire such as international knee documentation committee (ikdc) score - assesses knee function and symptoms, landing error scoring system (less), y balance (yb), functional movement screening (fms) statistical analysis will be performed to compare the functional performance and neuromuscular parameters between the groups in order to determine the most effective intervention for restoring movement quality after acl injury .

the study's emphasis on cross bracing protocol and dns training is warranted due to the necessity of investigating non-invasive and conservative therapy methods that have the ability to improve functional movements in athletes with acl injury . cross bracing is frequently employed to offer external reinforcement and enhance stability to the knee joint subsequent to an acl damage, whereas dns training concentrates on reconditioning the neuromuscular system to enhance movement patterns and motor control. the study seeks to provide significant insights into the most effective rehabilitation regimens for athletes with acute acl injury by evaluating the effects of two therapies. the ultimate goal is to enhance their functional results and long-term sports performance.

Eligibility criteria:
inclusion criteria: * male and female * age: 18-30 years. * mentally and verbally capable of participating in the study. * positive lachman test * diagnosis of acute acl injury with grade 1 and 2 through mri or arthroscopy. exclusion criteria: * inflammatory disease, rheumatoid arthritis, spondyloarthropathy or active malignancy. * neurological disorder or systemic disease. * previous surgery on the affected knee. * meniscal tear or articular cartilage damage requiring surgical repair

Keywords: anterior cruciate ligament cross brace movement dynamic stabilization functional movement
atorvastatin effectiveness and safety in cardiology patients in real world setting

Conditions: Coronary Artery Disease, Hypercholesterolemia, Hypertension

Summary: the study is to verify atorvastatin effectiveness and safety in chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ascvd。


Eligibility criteria:
inclusion criteria: * men and women aged ≥18 years; * cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. these patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia. * baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and creatine kinase (ck) value. the date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy. * evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit. exclusion criteria: * patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment * concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
reduced chemotherapy in low risk dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: this is a clinical trial to compare the efficacy and safety of four cycles of r-chop followed by four cycles of rituximab with six cycles of r-chop followed by two cycles of rituximab in the treatment of de novo, low-risk, non-bulky diffuse large b-cell lymphoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed de novo diffuse large b-cell lymphoma, complete response after 4 cycles of standard r-chop21 * age\>=14 y.o.,\<=75 y.o. * ipi=0-1 * non-bulky (largest diameter \<7.5cm) * ecog =0-1 * life expectancy\>6 months * informed consented exclusion criteria: * chemotherapy before * stem cell transplantation before * history of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * primary cutaneous, cns dlbcl * lvef≤50% * other uncontrollable medical condition that may that may interfere the participation of the study * lab at enrollment(unless caused by lymphoma) neutrophile\ 2\*uln,akp or bilirubin \>1.5\*uln creatinine\>1.5\*uln * not able to comply to the protocol for mental or other unknown reasons * pregnant or lactation * if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled. * hiv infection
copenheart ie - integrated rehabilitation of patients treated for infective endocarditis

Conditions: Infective Endocarditis

Summary: the aim of the study is to describe the effect and meaning of an integrated rehabilitation programme, consisting of physical training and psycho-educational care, for patients treated for infective endocarditis. the hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.

infective endocarditis (ie) is among the most serious infectious diseases in the western world. treatment requires lengthy hospitalization, high dosage antibiotics and possible valve replacement surgery. studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work, up to a year post-discharge. no studies investigating the effect of, interventions aimed at relieving these problems, have been published. a randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients treated for ie. the trial is a multi-centre, parallel arm design. a mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. the intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. a qualitative and a survey-based pre-study will be undertaken, to investigate post-discharge experiences and rehabilitation needs of patients treated for ie. a qualitative post-intervention study will explore rehabilitation participation experiences. the hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, nutritional status, sleep-quality and body-image and reduce anxiety, depression, fatigue, health care utilisation, work cessation and mortality in patients treated for ie and that it is cost effective. 150 patients treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis will be included in the trial questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme.

Eligibility criteria:
inclusion criteria: patients: * treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis based on duke criteria * 18 years or older * speaking and understanding danish * providing written informed consent exclusion criteria: patients: * unable to understand study instructions * with an ischemic event within the past 6 months * who are pregnant or breastfeeding * with reduced ability to follow the planned programme due to i.e. substance abuse problems or other somatic illness * with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training * whose physician advise against participation

Keywords: rehabilitation exercise training psycho-educational care
tdcs(transcranial direct current stimulation) efficacy in bipolar depression : rct study

Conditions: tDCS

Summary: the purpose of this study is to determine whether transcranial direct current stimulation (tdcs) is effective and safe in the treatment bipolar depression. randomized, double-blind controlled clinical trial. subjects adults (between 19 and 65 years of age) with bipolar depression who meet the inclusion criteria and who agree to participate in the study will recruit from clinical referrals. * active tdcs anode - left dlpfc cathode - right dlpfc electric current is 2ma - current is applied for 30 min * sham tdcs same assembly is used current is applied for 1 min both groups 30\~42 stimulation sessions on consecutive days. baseline(visit 1), 2 week(visit 2), 4 week(visit 3), 6 week(visit 4), and 12 week(visit 5) check compliance with mobile application(mindd-connect) connections.

assessment: depression rating scale: ham-d(hamiltion depresiion rating scale), ham-a(hamilton anxiety rating scale) maniac rating scale: ymrs(young mania rating scale) cgi-bp(clinical global impression-bipolar) q-les-q-sf(quality of life enjoyment and satisfaction short form) q-les-q-q(quality of life enjoyment and satisfaction questionnaire) qeeg(quantitative electroencephalography) check compliance with mobile application(mindd-connect) connections.

Eligibility criteria:
inclusion criteria: * type i or type ii of bipolar disorder meets the current major depression diagnostic criteria in dsm-5 * cgi severity of lightness score ≥ 4 points * taking mood stabilizers for at least four weeks before the day of screening exclusion criteria: * a history of clinically significant internal neurological disorders or head injury * mental retardation or cognitive impairment that will affect to make a consent form. * patients at risk of suicide that may require hospitalization as determined by clinicians * a person who is determined to be excluded for using tdcs medical device for other reason (e.g. metal plate is inserted on head, etc.) * a person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem * a woman who disagree with medically allowed contraception\* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant \* medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, intrauterine device, etc. * pregnant woman or lactating woman * a person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons

Keywords: tdcs bipolar disorder depression
a comparative study between abp 501 and humira® in participants with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between humira® and abp 501 (new high concentration formulation) compared with continued use of humira® in participants with moderate to severe plaque psoriasis. this multi-center study is composed of two periods: a lead-in period of treatment with humira® followed by a randomized two parallel arm period.


Eligibility criteria:
inclusion criteria: * participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months * participants has a score of pasi ≥ 12, involvement of ≥ 10% body surface area (bsa) and static physician's global assessment (spga) ≥ 3 at screening and at baseline * participant has no known history of latent or active tuberculosis exclusion criteria: * participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis * participant has an active infection or history of infections * participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment * participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment * participant has received ultraviolet (uv) a phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or uv b phototherapy within 2 weeks prior to enrollment * participant has received topical psoriasis treatment within 2 weeks prior to enrollment

Keywords: adalimumab biosimilars tumor necrosis factor psoriasis area and severity index